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The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.

This device is not intended to be used for tubal ligation or female sterilization.

Both predicate PK AIM and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM instrument is to be used only with the Olympus ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.

The provided text describes a 510(k) premarket notification for the "PK AIM" device, a cutting and coagulation instrument. The submission aims to expand the device's intended use based on its substantial equivalence to previously cleared predicate devices.

However, the provided document DOES NOT contain the type of detailed information requested regarding specific acceptance criteria, comprehensive device performance data tables, sample sizes for training and test sets, expert qualifications, ground truth establishment methods, or the results of MRMC studies that would typically be found in a clinical study report or a more detailed performance evaluation section of a submission.

The document primarily focuses on demonstrating substantial equivalence by comparing the proposed device's design, materials, and technological characteristics to its predicates and summarizing performance testing that supports the expanded indications.

Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what information is available and indicate where the information is missing.

Request Details and Available Information from Document:

1. A table of acceptance criteria and the reported device performance

• The document does not explicitly state quantitative acceptance criteria (e.g., "sealing success rate must be > X%") or provide a detailed table of reported device performance against such criteria.
• Instead, it states that "All study endpoints were met" for lymphatic sealing and "Bench Ex Vivo Design Verification testing demonstrated that the requirements defined in the protocol were met."
• For the lymphatic sealing study, the reported performance is qualitative:
  • Proposed PK AIM: "All vessels sealed with the proposed PK AIM test article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
  • Predicate OFJ: "All vessel seals with the OFJ control article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
• The conclusion for the device's equivalence to the predicate OFJ in lymphatic sealing is "The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon."
• For the bench/ex-vivo tissue study, the conclusion is "This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ."

2. Sample sizes used for the test set and the data provenance

• Lymphatic Sealing Study (Test Set):
  • Sample Size: 1 animal (porcine model).
    • 15 mesenteric lymph vessels sealed with the test device (PK AIM).
    • 16 mesenteric lymph vessels sealed with the control device (Thunderbeat OFJ).
  • Data Provenance: Acute GLP (Good Laboratory Practice) study conducted by American Preclinical Services (APS) in Minneapolis, MN (USA). This is a prospective animal study.
• Bench/ex-vivo tissue study (Test Set):
  • The document states "ex-vivo swine liver, swine kidney and bovine cardiac muscle tissue" but does not specify the number of tissue samples or seals performed.
  • Data Provenance: GLP ex-vivo study conducted by American Preclinical Services (APS). This is a prospective bench study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: One "study surgeon."
• Qualifications of Experts: The document states "The study surgeon evaluated each seal..." but does not provide details on the qualifications or experience of this surgeon.

4. Adjudication method for the test set

• The document states: "The study surgeon evaluated each seal immediately post seal and then again 30 seconds to one minute post seal."
• This suggests a single evaluator (the study surgeon). Therefore, there was no multi-expert adjudication method mentioned (e.g., 2+1 or 3+1). The "ground truth" seems to be based on the real-time observation and assessment by the single study surgeon during the procedure.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This document describes the testing of an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a medical device (electrosurgical instrument), not an algorithm. The "performance" is the physical effect of the device on tissue, assessed by a human surgeon.

7. The type of ground truth used

• For the Lymphatic Sealing Study: Real-time expert observation and assessment by a single study surgeon (clinical endpoint observation: integrity of seal, tissue sticking, char, leakage of lymph, hemostasis). This is a direct physical outcome as ground truth.
• For the Bench/ex-vivo tissue study: Comparison of tissue changes from the test device to the predicate, likely assessed visually or histologically, and confirmed against defined protocol requirements (design verification). This is a direct physical outcome comparison.

8. The sample size for the training set

• This information is not applicable/not provided as this is a physical device submission, not an AI/machine learning device that would require training data. The "training" for this device would be its design and manufacturing processes, which are validated, not "trained" in the sense of machine learning.

9. How the ground truth for the training set was established

• Not applicable, as this is not an AI/machine learning device.

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The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes.

The provided text is a 510(k) summary for a medical device (Olympus PK AIM) and focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe a study that involves human readers, AI assistance, or complex ground truth establishment methods typically found in studies for AI/ML-based diagnostic devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and the nature of ground truth beyond engineering specifications, are not applicable to the information contained within this document.

The document describes performance testing of the device itself (electrical, physical, mechanical characteristics), not an AI algorithm's diagnostic performance.

Here's a breakdown of the applicable information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets its specifications. The general statement is that "All performance testing passed or met prescribed acceptance criteria." Specific quantitative results are not provided in this summary, but the categories of testing and their objectives serve as the acceptance criteria.

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not specified quantitatively. The document states "Summary of bench, Performance Testing (no clinical testing was conducted)." This implies that samples of the device were subjected to the physical and electrical tests listed, but specific numbers of units tested are not provided.
• Data Provenance: Not applicable in the context of clinical data. This is bench testing of a physical medical device.

The study described is retrospective in the sense that the testing was performed on the device prototypes/pre-production units to demonstrate substantial equivalence for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context refers to the defined engineering specifications and international standards which the device must meet, rather than expert interpretation of medical images or conditions. The tests measure objective physical and electrical properties.

4. Adjudication method for the test set

Not applicable. Testing involves engineering and laboratory measurements against predefined specifications, not human adjudication of subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrosurgical tool, not a diagnostic imaging device involving human readers or AI assistance in interpretation. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not contain an AI algorithm. Its performance is related to its physical and electrical functions, not computational interpretations.

7. The type of ground truth used

The "ground truth" for this device's performance testing is established by engineering specifications, international performance standards (e.g., ISO, IEC, ASTM), and comparison to the established performance of the predicate device. For instance, HF leakage must meet a certain maximum value as per a standard, or power outputs must be comparable to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.

This document describes a 510(k) premarket notification for the PK AIM electrosurgical cutting and coagulation device. The submission aims to demonstrate substantial equivalence to existing predicate devices, specifically for the additional claim of sealing vessels up to 3.0 mm in diameter.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds, as would be common for diagnostic AI/ML devices with performance metrics like sensitivity, specificity, or AUC. Instead, the performance testing focuses on demonstrating that the subject PK AIM is substantially equivalent to its predicates, particularly for the new vessel sealing claim, meaning its performance is comparable and raises no new safety or effectiveness concerns.

However, we can infer some performance metrics from the Summary of Performance Testing section:

2. Sample Size Used for the Test Set and Data Provenance:

The studies described are in vivo animal studies and ex vivo bench testing, not human patient data.

• Ex Vivo Bench Testing:

  • Sample Size: Not explicitly stated as a total number of vessels, but it confirmed sealing of 1.00 mm to 3.49 mm size arteries.
  • Data Provenance: Laboratory bench testing. (No country of origin specified, but typically conducted internally or at specialized testing facilities).
  • Retrospective/Prospective: Prospective.

• Acute GLP Study (Swine Model):

  • Sample Size: Quantities of 11 and 12 blood vessels were sealed by the subject PK AIM and predicate PK OMNI, respectively.
  • Data Provenance: Swine model, likely a controlled laboratory setting (GLP - Good Laboratory Practice implies a standardized, prospective study).
  • Retrospective/Prospective: Prospective.

• Chronic GLP Study (Swine Model):

  • Sample Size: 11 animals survived a minimum of 21 days. The number of vessels sealed per animal is not specified but would be multiple.
  • Data Provenance: Swine model, controlled laboratory setting (GLP).
  • Retrospective/Prospective: Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not describe the use of human experts to establish "ground truth" in the context of diagnostic performance (e.g., radiologists reviewing images). Instead, the studies involve direct observation, measurement, and pathological analysis by scientific personnel.

• Ex Vivo Bench Testing: Ground truth is established by objective measurements (e.g., visual confirmation of sealing, burst pressure measurements using pressure gauges/equipment). This does not involve expert consensus in the human interpretation sense.
• Acute and Chronic GLP Studies:
  • Histopathology Report: A Histopathology Report is attached to the acute study, implying pathological assessment. This would typically be performed by a veterinary pathologist or similar qualified expert in animal tissue analysis. The number of pathologists is not specified.
  • Necropsy Pathology: A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites was performed in the chronic study. This would also be conducted by a veterinary pathologist. The number of pathologists is not specified.
  • Animal Health Report: An Animal Health Report attached to the chronic study, suggesting assessment by a veterinarian or animal care expert.
  • Qualifications: "GLP Study" implies that all personnel involved in the study (including pathologists and veterinarians) would meet specific qualifications and adhere to good laboratory practice standards.

4. Adjudication Method for the Test Set:

Not applicable in the AI/ML diagnostic sense. The studies rely on objective measurements and pathological assessments, where "adjudication" between human readers is not a concept employed. Discrepancies in pathological findings, if any, would be resolved through standard pathology practices (e.g., review by a senior pathologist, consensus discussion).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an electrosurgical instrument, not an AI/ML diagnostic tool intended to assist human readers in interpreting data. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The PK AIM is a physical surgical device, not a software algorithm. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

• Ex Vivo Bench Testing:
  • Direct Physical Measurement: Burst pressure of sealed arteries, direct observation of sealing, measurement of artery size.
• Acute and Chronic GLP Studies (Swine Model):
  • Pathology: Gross examination, histopathology (microscopic examination of tissue samples), necropsy pathology.
  • Outcomes Data: Animal survival, qualitative assessment of health, comparison of sealed vessel sites to control.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's functionality comes from its engineering design and manufacturing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm.

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The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.

This 2 in 1 device has a pencil type handle and combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator. The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification summarizing the device, its intended use, comparison to predicate devices, and general performance testing for regulatory approval.

Here's a breakdown of what's missing:

• Specific Acceptance Criteria and Reported Performance: While various tests are listed (Dimensional Measurements, Expected Forces, Overall Design Testing, Biocompatibility, Packaging, ex-vivo bench top testing), the document does not report specific quantitative acceptance criteria or the numerical results/performance metrics for the PK AIM device. It simply states "All devices tested met specification and were graded as Pass" or "All devices passed ISO 10993 acceptance criteria and were graded as Pass," or "All ex-vivo results showed substantially equivalent results to the predicate devices."
• Study Design Details: The document mentions "ex-vivo bench top testing" but provides no details on:
  • Sample size used for the test set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication method.
  • MRMC comparative effectiveness study.
  • Standalone performance.
  • Type of ground truth used.
  • Sample size for the training set (if applicable, as this is a physical device, not an AI/ML diagnostic).
  • How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, design, and scientific technology, supported by general performance testing results that "met specification" or were "substantially equivalent." It does not provide the detailed study information you've requested.

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